EMA Approves Takeda’s TAKHZYRO Pre-Filled Pen for Subcutaneous Administration in Adolescent and Adult HAE Patients

25th February, 2025

The new 2 mL pre-filled pen option expands individualized treatment choices for hereditary angioedema (HAE) patients, reinforcing Takeda’s commitment to reducing disease burden and improving quality of life.


  • TAKHZYRO Solution for Injection in 2 mL Pre-Filled Pen is Now Approved to Facilitate Subcutaneous Administration in Adolescent (Aged 12 Years and Above) and Adult Patients with HAE.
  • The Pre-Filled Pen Option is Designed to Allow for An Individualized Treatment Approach for Adolescent and Adult HAE Patients.
  • In the EU, TAKHZYRO is Approved for Routine Prevention of Recurrent HAE Attacks in Patients Aged 2 Years and Older.

Takeda announced  that the EMA has approved an additional 2 mL pre-filled pen option for TAKHZYRO® (lanadelumab) for subcutaneous administration in adolescents (aged 12 years and above) and adult patients with Hereditary Angioedema (HAE).1

The additional subcutaneous administration option expands Takeda's offering in this space, showing dedication to the HAE community while providing individualized treatment options to support patients with a life-threatening disease, by helping to reduce HAE burden and improving their Quality of Life.

"HAE affects an estimated 1 in 50,000 people worldwide and is often under recognised, under diagnosed and under treated.We welcome the swift approval by the EMA on this additional subcutaneous administration option," said Irmgard Andresen, Global Medical Lead HAE at Takeda. "HAE patients 12 years and older now have an additional individualized treatment option available to them."

TAKHZYRO® (lanadelumab) is currently approved as 150 mg solution for injection in pre-filled syringe, 300 mg solution for injection in pre-filled syringe, and 300 mg solution for injection in vial.1 This approval for an additional subcutaneous administration option, TAKHZYRO® 300 mg solution for injection in pre-filled pen, containing 300 mg of lanadelumab in 2 mL of solution, was supported by a clinical study.2

Takeda is dedicated to providing innovative treatment options to support patients, particularly those from underserved communities, and continues its leadership in HAE treatment, supported by a noteworthy data pool from historical engagement in this area.

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